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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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synthes 3.9 mm pelvic screws SYNTHES (USA) k013044 12/03/2001
synthes calcaneal plate SYNTHES (USA) k020401 05/08/2002
synthes in-situ bender/cutter SYNTHES (USA) k021458 07/24/2002
synthes modular foot system SYNTHES (USA) k001941 09/22/2000
synthetic glass bone graft material BLUE SKY BIO k000633 05/25/2000
system 2000 controller, system 5000 controller, footswitch, power cord, and visage wandsff ARTHROCARE CORP. k020408 05/02/2002
tandem-cath 10 fr. catheter system, model multiple code numbers THE KENDALL COMPANY k002902 04/09/2001
tdp heat lamp or infrared heating lamp, models cqg-s1, cqg-111a/b, cqg-222a/b, cqg-270a/b, cqg-222d C&H INTERNATIONAL k020851 09/23/2002
tele-cliniq data transmission system blood pressure measurement system AEROTEL MEDICAL SYSTEMS (1998) LTD. k021447 05/22/2002
telesis digital infrared thermal image system, spectrum 9000mb TELESIS TECHNOLOGIES INC. k020783 06/07/2002

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